Trading within the UK and between the UK and Europe just got a lot more complicated

Despite the trade deal between the UK and the EU being hailed as a major success for both sides, the main benefits of the agreement focus on the elimination of trading tariffs and the equalisation of customs rules. So far as the single market (and hence the rules for CE marking) are concerned, the UK is now split up into two parts: Northern Ireland remains within the single market while Great Britain (i.e. Scotland, Wales and England) leaves the single market and is free to set its own rules.

This is what we know so far:

  • From 1 January 2021, the UKCA mark will start to replace the CE mark for goods sold within Great Britain.
  • The CE mark will continue to be required for goods sold in Northern Ireland.
  • Units already in the supply chain at the time the new rules come into effect can continue to be sold under the old rules.
  • For most CE marked goods there will be a one year transition period commencing on 1 January 2021, during which time the CE marking will continue to be acceptable as an alternative to the UKCA mark for goods sold in Great Britain.
  • Some goods (e.g. certain medical devices) will have an extended transtion period up to 2023.
  • For all other goods, the UKCA mark will become mandatory at the end of 2021.
  • Products will be able to display both the UKCA mark and the CE logo unless and until the rules for those products diverge between the UK and EU.
  • It's not expected that any divergence will happen in the near future.
  • Products which require third party (i.e Notified Body) involvement as part of their CE marking process will have to use a UK Approved Body instead of (or as well as) an EU Notified Body - see below for more details.
  • Manufacturers based within Great Britain will need to identify a representative based within the EU whose name and address can go on the product as a contact point for the Market Surveillance Authorities.
  • Manufacturers based outside the UK and selling in the UK will need a UK based representative.

 

The UKCA Mark

The UKCA mark is the replacement for CE marking in Great Britain. Applying the UKCA mark is exactly like using the CE logo. The Regulations and Directives which created the legal structure for CE marking have now been adopted into UK law and updated to change the terminology and to bring them completely within the control of the UK government.

The following table summarises the terminology equivalence:

 Replace EU references to:  With UK references:
 This Directive  These regulations
 Other EU directives  Other enactments
 CE Mark  UKCA Mark
 Harmonised standards  Designated standards
 Publishing standard titles in “Official Journal of the EU to harmonise them  The Secretary of State will designate standards and publish their titles 
 EU declaration of conformity  Declaration of Conformity
 Union harmonisation legislation  Statutory requirements
 EU-type examinations, certificates, etc.  Type examinations, certificates, etc.
 EU, EU member states, EEA, EEA member states.  The United Kingdom
 Established in the Union (manufacturers, importers, authorised  representatives, etc.)  Established in the United Kingdom
 A language which can be easily understood by … (by end-users, authorities, etc.)   English
 Omit references to competent national authorities of other Member States  (Consideration of other member states is not required)
 UK Notified bodies  Approved bodies

To apply the UKCA mark, manufacturers have to do exactly the same things as they did to apply the CE mark, and in most cases they can use the same standards, risk assessments, test data, and technical files so the only thing which changes is the logo on the product and the words on the Declaration of Conformity.

Products being sold in the EU as well as Great Britian will continue to need the CE logo, so most products will have both the UKCA mark and the CE logo on them. 

Standards

Those familiar with CE marking will know that the key to the process is the correct application of standards to provide detailed design guidance and recommended solutions for complying with the safety requirements of the CE Directives and Regulations.

Standards will continue to form the bedrock of the product safety landscape in the UK after Brexit. The UK Government will publish lists of 'designated standards' which can be used as the basis of conformity with the UKCA requirements, in exactly the same way as harmonised standards provide a presumption of conformity for CE marking.

Standards will continue to be published in the UK by the British Standards Institute. BSI remains a member of CEN and CENELEC until at least the end of 2021, but only as an EEA member, not as a full EU member. This means BSI's influence on the drafting of harmonised standards is diminshed.

It's not currently clear what happens to the UK's obligation to withdraw conflicting national standards and replace them with harmonised standards once BSI is no longer a full member of CEN or CENELEC. The obligation is part of the CEN/CENELEC agreement which national standards bodies must sign up to if they are to become full members and it's probably the most significant factor in the harmonisation of products for sale across the single market. However, it's difficult to see how the commitment to withdraw conflicting national standards is compatible with the full national sovereignty aspect of Brexit. The new UK-EU agreement includes words which indicate that the UK will focus on standardisation at an 'international' level but quite what that means in practice remains to be seen. 

Notified Bodies, Approved Bodies

Notified Bodies have an important role to play in the CE marking of many products. The Notified Body may be involved in type testing the design or in ensuring the consistency of production (quality control), or both. Where the Notified Body is involved in checking the conformity of production, their four figure number must accompany the CE logo on the product.

Notified Bodies must be located in an EU Member State, or in a territory where there is a mutual recognition agreement (MRA) between that territory's government and the EU. There is (currently, at least) no such MRA between the UK and the EU, so all Notifed Bodies based in the UK cease to be notified at midnight on 31 December 2020

Most UK based Notified Bodies have now opened offices in European states and have had these appointed as EU Notified Bodies by the EU country where they are based so they can continue to provide Notified Body services in the CE marking field to their clients.

The UK Government has now appointed all the UK based Notified Bodies who requested transfer as UK Approved Bodies. They retain their four figure EU Notified Body number which must go on products alongside the UKCA mark if required. Approved Bodies can only approve products which are UKCA marked and intended for sale within Great Britain, and EU Notified Bodys can only approve products for CE marking, so a manufacturer who wishes to sell both in the EU and in the UK must appoint both a UK Approved Body and an EU Notified Body. In practice, in most cases this can be the same organisation so long as it has a commercial presence and accreditiation in the UK as well as Europe.

The situation in Northern Ireland is more complicated still, because a UK Approved Body cannot approve goods for CE marking.  The following table summarises the situation, although it's worth noting that some aspects of the arrangements for Northern Ireland are still not fully settled. Further guidance from the UK government is expected soon.

Export of new products (CAB INVOLVED) placed on the market     To
 GB  NI  EU  Non-EU/EEA
From      GB CE mark using EU Notified Body (OK until 1st Jan 2022).

UKCA mark using UK Approved Body (can be used from 1st Jan 2021, mandatory from 1st Jan 2022).
N.B. Actual UKCA mark on the product does not need to be attached until 1st Jan 2023.

Either:

CE mark using EU Notified Body, or

CE mark + UK(NI) mark using UK Approved Body from 1st Jan 2021.
Not certain - more UK government information to follow.

 
CE mark using EU Notified Body  Local laws apply 
 NI Three options:

UKCA mark (can be used from 1st Jan 2021) using UK Approved Body,

CE mark using EU Notified Body, or

CE mark + UK(NI) mark using UK Approved Body from 1st Jan 2021.
Not certain - more UK government information to follow.

Either:

CE mark using EU Notified Body, or

CE mark + UK(NI) mark using UK Approved Body from 1st Jan 2021.
Not certain - more UK government information to follow.

 
CE mark using EU Notified Body.  Local laws apply 
 EU
CE mark using EU Notified Body (OK until 1st Jan 2022).

UKCA mark using UK Approved Body (can be used from 1st Jan 2021, mandatory from 1st Jan 2022).
N.B. Actual UKCA mark on the product does not need to be attached until 1st Jan 2023.

CE mark using EU Notified Body. CE mark using EU Notified Body. Local laws apply
 Non-EU/EEA

CE mark using EU Notified Body (OK until 1st Jan 2022).

UKCA mark using UK Approved Body (can be used from 1st Jan 2021, mandatory from 1st Jan 2022)
N.B. Actual UKCA mark on the product does not need to be attached until 1st Jan 2023.

 

Either:

CE mark using EU Notified Body, or

CE mark + UK(NI) mark using UK Approved Body from 1st Jan 2021.
Not certain - more UK government information to follow.

 
CE mark using EU Notified Body. Local laws apply 

 

Export of new SELF
CERTIFIED products placed on the market

To    
 GB  NI EU   Non-EU/EEA
From      GB  

CE mark (can be used up until 1st Jan 2022).

UKCA mark (can be used from 1st Jan 2021, mandatory from 1st Jan 2022)
N.B. Actual UKCA mark on the product does not need to be attached until 1st Jan 2023.

 

CE mark

 

 

CE mark

 

Local laws apply 
 NI  

Either,

UKCA mark (can be used from 1st Jan 2021), or

CE mark

CE mark  CE mark  Local laws apply 
 EU

CE mark (can be used up until 1st Jan 2022).

UKCA mark (can be used from 1st Jan 2021, mandatory from 1st Jan 2022).
Actual UKCA mark on product does not need to be attached until 1st Jan 2023.

 
CE  mark CE mark  Local laws apply
 Non-EU/EEA

CE mark (can be used up until 1st Jan 2022).

UKCA mark (can be used from 1st Jan 2021, mandatory from 1st Jan 2022).
Actual UKCA mark on product does not need to be attached until 1st Jan 2023.

 
CE mark CE mark Local laws apply

 Authorised Representatives

After 31 December 2020, the UK will no longer be part of the EU and the transitional arrangements will have expired. This means that any requirement in the CE marking legislation which mandates a presence within the EU can no longer be fulfilled by a UK based office.

Such requirements include the need to identify an Authorised Representative for medical devices, the requirement for an address within Europe for the 'person authorised to compile the technical file' for machinery and the need to identify an EU importer for most of the other CE marking directives and regulations

This means that manufacturers based outside the EU will need to come to an arrangement with someone who can fulfil this obligation from 1 January 2021. Furthermore, manufacturers based outside the UK who wish to sell products into the UK market will also need a representative within the UK. This is covered in much more detail on our Authorised Representative page.

In summary...

Here are the most important points to take away:

  • Don't panic! For most products manufacturers still have until the end of 2021 to get themselves organised to apply the UKCA mark.
  • For the moment, the technical requirements for the UK and EU markets remain identical, it is only some of the administrative paperwork which changes.
  • Manufacturers selling within the EU will need to ensure they have representation in the EU, and manufacturers selling within the UK must have representation within the UK. 

 

As ever, Conformance is here to help you get to grips with these changes. Contact us if you need help.

 

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